ES2343118T3 - DEVICE THAT OCCUPIES INTRAGASTRIC VOLUME OF AUTOINFLATE. - Google Patents

Abstract

A self-inflating, intragastric balloon device (1) is activated by addition of an activating liquid into an acid or water soluble receptacle (b) located within the bladder (2). After an approximately pre-determined time period post-activation, the activating liquid breaches the receptacle wall and causes contact between an acid in liquid form and an emissive substance within the bladder, causing it to inflate. The device is conveniently provided to medical personnel as part of a kit that further contains a syringe and the activating liquid. The device also can have acid or pepsin degradable portions that cause it to deflate after residing in the stomach for a prolonged period of time during which it imparts a feeling of satiety in the patient.

Description

Device that occupies intragastric volume of self-inflated

Field of the Invention

The present invention relates to devices doctors to control appetite and, more particularly, to balloons intragastric

Background of the invention

Obesity is a fundamental health problem in developed countries. In the United States, the complications of Obesity affects about one in five individuals at a cost annual of approximately 40 billion dollars. Except for strange pathological conditions, weight gain is directly correlated with excess feeding.

Non-invasive methods to reduce weight include either increasing metabolic activity or burning calories or reduce caloric intake, either by modifying the behavior or with a pharmacological intervention to reduce the desire to eat Other methods include surgery to reduce the stomach volume, position bands to limit the size of the stomach and intragastric devices that reduce the desire to eat Occupying stomach space.

The devices that occupy volume Intragastric provide the patient with a feeling of satisfaction after eating only small amounts of foods. Therefore, caloric intake is decreased while the subject is satisfied with a feeling of satiety. The devices that occupy volume currently available have Many inconveniences. For example, complex procedures of gastrostomies are required to insert some devices.

The clinical use of intragastric balloons has been developed over several years, and its success in the treatment of Certain individuals with morbid obesity are quite accepted. The volume-occupying devices for use in reducing Obesity developed in the late 1970s and early 1980s. These first designs had multiple complications that caused them not to gain wide acceptance in that moment. The new designs were developed in the late 1980s, and has resulted in its wide acceptance in European clinics.

U.S. Patent No. 4,133,315 describes an apparatus to reduce obesity comprising a inflatable elastomeric bag and a tube combination. Agree With U.S. Patent No. 4,133,315, the bag can be Insert into the patient's stomach by swallowing. Tube end Fixed distal of the bag remains in the patient's mouth. A second tube is introduced meandering through the cavity nasal inside the patient's mouth. Tube ends located in the patient's mouth connect to form a tube continued to communicate fluidly through the nose of the patient with the bag. Alternatively, the bag can be implant through a gastronomic procedure. The bag inflates through the tube to a desired degree before the patient eat in a way that reduces the desire to feed. After that the patient has eaten, the bag deflates. As taught by US Patent No. 4,133,315, the tube is extends out of the patient's nose or abdominal cavity to Through the course of treatment. United States Patents No. 5,259,399, 5,234,454 and 6,454,785 describe a device that occupies intragastric volume for weight control to be implanted Surgically

U.S. Patents No. 4,416,267, 4,485,805, 4,607,618, 4,694,827, 4,723,547; 4,739,758; 4,899,747 and European Patent No. 246,999 refers to devices that occupy intragastric volume for weight control that can be insert endoscopically. Of these, the State Patents United States 4,416,267, 4,694,827, 4,739,758 and 4,899,747 refer to balls whose surface is contoured in a certain way to get a desired finish In U.S. Patent Nos. 4,416,267 and 4,899,747, the ball is shaped like a bull with a central opening flared to facilitate the passage of solids and liquids through The stomach cavity The US Patent Ball No. 4,694,827 has a plurality of surface convex projections uniform. The protrusions reduce the amount of surface area that makes contact with the stomach wall, reducing in this way the harmful effects that result from excessive contact with the mucosa gastric The projections also define channels between the ball and the stomach wall through which solids can pass and liquids The US Patent Ball No. 4,739,758 it has blisters on its periphery that prevent it from being seat firmly against cavities or pylorus.

United States Patent Balls No. 4,899,747 and 4,694,827 are inserted by pushing the deflated balloon and fixing it so that it can be released by tubing down a tube gastric. U.S. Patent No. 4,723,547 describes a insertion catheter specially adapted to position this ball. In U.S. Patent No. 4,739,758, the tube of load makes the insertion of the ball. In the patent of States United No. 4,485,805, the ball is inserted into a finger that is fixed by a rope to the end of a gastric tube conventional that is inserted internally from the throat of the patient. The European patent ball No. 246,999 is inserted using a gastroscope with integral forceps.

In U.S. Patent Nos. 4,416,267, 4,694,827, 4,739,758, 4,899,747, 4,485,805 and in the European patent No. 246,999, the balloon is inflated with a fluid from a tube that is extends down the patient's mouth. In these patents, the ball is also provided with a hollow of self-sealing (4,694,827), an injection site (4,416,267, 4,899,747), a load valve self-sealing (4,485,805), valve self-closing (EP 246.999) or duckbill valve (4,739,758). U.S. Patent No. 4,723,547 uses a plug elongated thickness and the balloon is loaded by inserting a needle attached to an air source through the plug.

US Patent No. 4,607,618 describes a folding apparatus formed of semi-rigid structural members joined to form a hollow folding structure. The device is not inflatable. It is inserted endoscopically into the stomach using a specially adapted endotracheal tube that has an ejector rod to release the folding device. Once released, the device returns to its maximum dimension and shape.
boasting

None of the above patents describe a device that occupies free floating intragastric volume that can be inserted into the stomach simply by swallowing it the patient and letting peristalsis supply it in the stomach in the same way that food is supplied.

U.S. Patent No. 5,129,915 is refers to an intragastric balloon that is intended to be swallowed and It automatically inflates under the effect of temperature. The U.S. Patent No. 5,129,915 describes three ways in which that an intragastric balloon can be inflated by a change in the temperature. A composition comprising a solid acid and a Non-toxic carbonate or bicarbonate is separated from water by a Chocolate coating, cocoa paste or cocoa butter It melts at body temperature. As an alternative, the acid citrus and an alkali bicarbonate coated with vegetable fat or non-toxic animal that melts at body temperature and that placed in the presence of water, it would produce the same result. By Lastly, solid acid and non-toxic carbonate or bicarbonate are insulate from water by an insulating bag made of synthetic material low resistance that will be enough to break immediately before that the air chamber runs out. Breaking the bags insulation causes the acid, carbonate or bicarbonate to mix and the water and the ball begins to expand immediately. A inconvenience of the thermal activation of the inflation as it has been suggested in U.S. Patent No. 5,129,915 is that no get the degree of control or the reproducibility of the inflation time that is desirable and necessary in a ball Intragastric safe self-inflation.

After swallowing, food and medication Oral reach the patient's stomach in less than a minute. He food is retained in the stomach on an average of one to three hours. However, residence time is highly variable and it depends on such factors as fasting or feeding status of the patient. Inflation of an intragastric balloon of self-inflated must be timed to avoid premature inflation in the esophagus that could lead to esophageal obstruction or late inflation that could lead to intestinal obstruction.

Still, there is a need for a free floating intragastric balloon device that can supplied to the stomach by conventional oral administration and that it can inflate in a controlled way after a period of delay time approximately predetermined.

The European patent application number EP-A-0103481 describes a device anti-obesity that is self-contained and capable of being swallowed and Receive inside the stomach. The device comprises a wrap capable of dilating inside the stomach through a diversity of means such as the breakage of a capsule that It contains water that then reacts with a bicarbonate mixture sodium and citric acid to develop carbon dioxide.

In International Patent Application Number PGT / GB1986 / 000392, published as WO87 /
00034 describes an inflatable balloon that is placed in the stomach to treat obesity by reducing food appetite. The balloon can be inflated by supplying liquids thereto through a supply line, by the gaseous reaction product of a chemical reaction within the balloon or by absorbing liquids through its semipermeable wall. The balloon is preferably peripheral or ellipsoidal. The supply to the stomach of the balloon and the supply line by means of an over-tube with a smoothly closed finish presentation is achieved by providing a totally limiting lateral groove in the over-tube from which the balloon leaves the over-tube during inflation. The ball valve and the supply line are preferably a mutual friction fitting, which allows traction only on the supply line to leave the free floating ball in the stomach after inflation.

Brief description of the figures

Figure 1 represents section views cross-sections of an intragastric device of self-inflated according to the invention: (a) a device that has an emission substance that is contained within the lumen of the ball, (b) a device that has a emission substance and a solid acid contained within the lumen of the balloon, (c) a device that has an emission substance contained in the lumen and a solid acid contained in a container separated, and (d) a device that has an emission substance contained in the container and a solid acid contained in the lumen of the ball.

Figure 2: (a) represents a device of according to the invention enclosed in a container as it could received by the nurse or doctor who will administer it, (b) represents the activation of the device by communication of a acid through a self-sealing valve in a acid degradable vessel, (c) represents the device shortly after being swallowed by the patient, (d) represents the device after reaching the stomach, having broken the container, the balloon starting to inflate and the container starting to degrade, (e) the partially inflated device, and (f) the fully inflated device.

Summary of the invention

In a first aspect, the present invention provides an intragastric device of self-inflated that is useful for curbing appetite and that dilates the stomach of a patient who undergoes a medical procedure. The device includes a balloon substantially impervious to liquids containing a substance of emission that emanates a gas when it makes contact with an acidic liquid and that contains a container that encloses a space isolated from the emission substance Fluid communication from outside the balloon to the container is made possible by a valve self-sealing

The device self-inflates in an approximately predetermined time after activation. The device is activated by communicating a liquid from activation of the outside of the ball inside the container. He container is made, at least in part, of a protective material soluble, which is penetrated by the activation fluid after of an approximately predetermined delay time period. The device is administered to the subject during this period of weather. The penetration of the vessel produces the mixing of the acid and the emission substance which results in the emission of gas and inflation of the ball.

Preferably, the device is sized and is formed so that it can be swallowed by the subject to whom will manage Alternatively, the device can be managed using endoscopic equipment known to those in the techniques medical

The device can be supplied as part of a kit for medical staff who will administer the device in a non-toxic container that is sized to pass down the esophagus of the subject to whom it will be administered. The kit can also contain a pre-filled syringe or other liquid container of activation.

In another aspect, the invention provides a intra-gastric self-inflated medical device and self deflation. The medical devices of according to this aspect of the invention include at least one portion of the device made of an acid degradable material or of pepsin Such portions include the chamber portion of balloon air, self-sealing valve and a clamp that can be provided to hold the valve self-sealing in a fluid tight coupling With the air chamber.

Detailed description of the preferred embodiments

In a first aspect, the invention provides an intra-gastric self-inflating medical device useful for curbing appetite for the purpose of promoting weight loss. The device is also useful for dilating the stomach that undergoes a surgical procedure. For example, it is known that intragastric balloons may be useful in performing a percutaneous gastrostomy. VanSonnenberg, Eric et al . Radiology 1984, 152, 531. The medical device includes a balloon that occupies volume and means to inflate the balloon once an approximately predetermined period of time has elapsed after activation.

The operation of the medical device intra-gastric self-inflation is better understood by Consider its functional components. The device includes a balloon whose dimension is determined by the pressure of a fluid, in this case a gas, within the lumen of the ball. When inflated, the gas pressure inside the ball causes it to occupy a volume substantially greater than the volume it occupies when the gas pressure inside the balloon is the same or less than the pressure Ambience outside the ball. The balloon of this medical device occupies a substantial volume when inflated, preferably of about 200 cm3 to about 800 cm3 in order to contribute significantly to the feeling of satiety when the device is used to curb appetite or to dilate significantly the stomach when undergoing a medical procedure. However, for any of these purposes is within the contemplation of the invention insert one, two, several or more balls in the stomach of the subject to whom It manages the device. Although the uses with which the invention is more immediately related refer to beings human and medical treatments that are appropriate for them, the invention also has veterinary applications particularly for mammals. A ball of one dimension Different may be appropriate for a veterinary application.

The intragastric medical device of Self-inflated is sized to pass through the esophagus. The ball must be in a deflated condition to allow passage through the esophagus. In the condition of deflated, the lumen dimension of the balloon is minimized. By both, before administration and preferably during manufacturing, the balloon is sealed at an ambient or reduced pressure in relation to the pressure outside the ball. The device can be position in a patient's stomach by inserting it internally from the throat while the patient is under sedation using Well-known medical instruments. Preferably without However, the device is swallowed by the patient and transported to the stomach by peristalsis.

The ball is self-inflated in the stomach of the subject without any external source such as a syringe or pump that supplies fluid to it while it is inflating. Therefore, it does not require fixed supply lines that they come out of the patient's mouth or they go through the wall of the stomach to provide inflation of the fluid from a source external

In the present invention, the Self-inflated is achieved by the reaction of an acid with an emission substance in the lumen of the ball which gives as Gas generation result. Inflation occurs due to the substantial fluid impermeability of the balloon and greater volume occupied by the molecules of a gas that the same number of solid molecules at the same temperature and pressure.

Useful acids in the device include acetic acid, nitric acid and solutions thereof and solutions  of hydrochloric acid. A preferred solvent to prepare solutions is water even though the acid can be sufficiently soluble in another solvent, such as ethanol, that the replacement of another solvent is acceptable, as long as the Alternative solvent does not cause the subject to experience effects Adverse sides

The emission substance releases the gas when makes contact with a solution of citric acid, acetic acid or solution thereof, or a solution of hydrochloric acid (despite that other acids can be used, an emission substance that releases gas after contact with them will also release gas, with in general, when it makes contact with the preferred acids of the invention). Preferred emission substances are carbonates and alkali metal bicarbonates and solutions, preferably aqueous solutions thereof. Especially the substances of Preferred emissions are sodium bicarbonate (NaHCO3) and potassium bicarbonate (KHCO3) that release carbon dioxide when they react with the acid.

In addition to the emission substances, the ball encloses a container that defines a space separated and isolated from the rest of the lumen of the ball. The container is formed, at least in part of a soluble protective material. Protective materials Soluble are rigid thermoelastic materials that melt by above 30 ° C more preferably above 50 ° C. The soluble protective materials dissolve in water, acids organic that are liquid at room temperature or solutions of mineral or organic acids. Soluble protective materials that meet these criteria include, but not necessarily limited to gelatin, xanthan gum and cellulose derivatives and compositions described in US Pat. No. 5,431.9917 and the Japanese Patent Open to Public Inspection No. 61-100519 and 62-26606, and the like, with gelatin being the most preferred soluble protective material.

To prevent premature inflation of the ball, the acid and the emission substance (or substances) are isolated from each other until the ball is inserted into the subject's stomach. There are several ways by which the acid and substance of emission can be isolated from each other according to this invention. A solid acid and a solid emission substance may be in physical proximity or even in contact with the lumen of the ball and still chemically isolate because both are in a state solid in which they are not able to react or Generate the gas Alternatively, they can be physically isolated positioning one in the container and the other in the lumen of the ball. Therefore, as used in this description, the term "isolated" means physical separation by a protector and chemical separation due to the solid physical state of the acid and the emission substance

In one embodiment, the intragastric device Self-inflated includes a deflated balloon that it contains an emission substance and an empty container in its lumen In alternative embodiments, the ball also contains a solid acid, in which case the device can be adjusted to any of the following embodiments: (1) the solid acid is placed inside the container and the emission substance is placed in the lumen of the balloon, (2) the solid acid and the emission substance they are placed in the lumen and the container is emptied and (3) the acid solid is placed in the lumen and the emission substance is placed in the recipient. A preferred solid acid for these embodiments It is citric acid.

The intragastric device of self-inflating of the present invention can be provide appropriately trained medical personnel as part of a kit Also, a container such as a vial is supplied, pre-filled vial or syringe containing a Activation liquid as part of the kit. The nature of the liquid activation depends on whether the ball is provided with an acid solid. In an embodiment in which the balloon does not contain an acid solid, the activation liquid is well an organic acid that is liquid at room temperature or a solution of a mineral acid or organic. In an embodiment in which the balloon contains an acid solid, the activation liquid can be basically any aqueous solution whose solutes do not interfere with the inflation of balloon, the preferred activation liquid being substantially in such embodiments pure water. The bibliographies that contain instructions on how to activate, manage, use and / or leave of using the device can also be supplied as part of the kit

The acid and emission substance are made react after a period of delay approximately predetermined by activating the device before the administration to the patient, preferably within a minute before administration. To activate the device, the liquid Activation is communicated inside the container. The communication of the activation fluid inside the container begins with the dissolution of the container, or the soluble portion thereof, leading to a penetration of the vessel wall. After that penetration, acid and emission substance occur cease to be isolated; they react by releasing the gas and causing the ball to inflate. This should happen only after that the device is in the patient's stomach. Therefore the activation liquid and the soluble material from which it is formed the vessel is selected with a view to control the period of time between device activation and when The inflation begins. If this period of time is too short, The balloon can clog the esophagus. If said period of time is too long, the ball can pass from the stomach into the intestine before inflating and causing a bowel obstruction. For a minimum risk of these possibilities, a period of time delay of about 1 minute to about 10 minutes It is optimal, although it may vary depending on the patient. In spite of than other combinations of activation liquid and material soluble can reach a routine experimentation, the following combinations have been found suitable in the practice.

In a previously described embodiment of the intragastric self-inflated device, the balloon It contains the emission substance in the lumen and an empty container, Without a solid acid. For this embodiment, a protective material preferred soluble from which at least a portion of the Bowl is jelly. Preferred activation fluids for this embodiment are mixtures of approximately 25% at approximately 50% (v / v) acetic acid and approximately 50% to about 75% (v / v) water, more preferably of approximately 33% acetic acid and 67% (v / v) of Water.

In a second embodiment of the device intragastric self-inflated, the balloon contains the emission substance in the lumen of the balloon and a solid acid, such as citric acid, in the bowl. In this embodiment, the liquid from Preferred activation is water. After communication within container, the water dissolves the solid acid and dissolves the container, such that after penetration of the wall from the container an acid solution makes contact with the substance emission, so they react to release gas and inflate the ball.

In another embodiment of the medical device of self-inflation of this invention, the balloon contains both solid acid and the emission substance in the lumen and the Container is empty In this embodiment, the liquid from Preferred activation is water. After communication within container, the water dissolves at least a portion of the container and After penetration of the container, the lumen of the balloon enters the that solid acid dissolves and the emission substance causing that they cease to be chemically isolated and are capable of react to produce gas.

To activate the balloon, the activation fluid communicates from outside the ball (which must be substantially impenetrable liquid after all) until the container, preferably by means of a valve self-sealing In this description, the expression "self-sealing valve" is widely used to include any portal that can be opened to allow fluid communication from one side of the portal to the other side and close or seal itself without mechanical manipulations uncomfortable The types of articles covered by the expression include a septum and a duckbill valve, such as those described in U.S. Patent No. 4,739,758. A septum is an elastomeric body or segment that reaches a hollow needle and that deforms to close the gap left by the needle after withdraws Known valves of the type that have cores Swivel or sliders attached with a valve seat are not preferred for this application because they are typically too large for conventional oral administration and, if sized for easy administration, they would be uncomfortable to operate, delicate and / or similarly cause discomfort while they were in the patient's body. Of course such valves are properly used in the equipment used together with the device such as a syringe if so desired always and when they are not connected so that they cannot be released to device. Preferably, the valve Self-sealing is a septum. As will be described more in detail below. The septum may be a discrete part of the balloon attached to a component of the air chamber of the balloon with a seal substantially impermeable to liquid or it can be a segment of a ball formed of a self-sealing material which is identified, for example, by markings on the surface outside of the ball.

The container can be connected to the valve self-sealing through a conduit through which the activation fluid is passed to reach the container. As an alternative and even more preferable, the valve self-sealing is a septum and the lateral septum facing the inside of the ball forms a wall of the container. In such a construction, the container is formed and is defined by a fixation of a receptacle made of a soluble protective material that has a mouth towards the inner side from the septum Therefore, the combination of the septum and the receptacle defines the size and shape of the container and the space that enclose The activation fluid communicates directly with the container by inserting the needle tip of a syringe that contains the activation fluid through the septum and advance  to the plunger The plunger can then be removed and advanced again one or more times to allow air to escape from container. Alternatively, the container can be ventilated inserting the tip of a second hollow needle (which does not need look at the syringe) through the septum through which you can escape the air. Another alternative is to evacuate the container, what which can be achieved by coinciding with the evacuation of the balloon, if so desired, during manufacturing.

After the device has been activated, the device is administered to the patient. Although the duration of approximately predetermined delay time until inflation it will affect the speed with which the activated device is due administer, administration should occur shortly after the activation, preferably within one minute after same. Although the device can be administered using techniques quite a few known gastric endoscopy known in the art, the device is preferably administered orally as would administer a capsule or tablet, the patient swallowing the device. To facilitate the drink, the device can Also comprise a container. The packaging must be made of a material that dissolves in gastric fluid faster than the container, or that a soluble portion thereof dissolves in the activation fluid. To insert the balloon into the container, the deflated or evacuated balloon is compacted, rolling it up, folding it or compacting it in a small mass enough to be inserted inside the container. While compacting, it should be taken Be careful that the self-sealing valve is exposed on the surface of the compacted ball. The container is preferably transparent, semi-transparent or marked for facilitate the identification of the valve self-sealing after the ball has been compacted When the valve location of self-sealing is visible from outside the container, the device can be activated while in the container simply piercing the container with the needle used to inject the acid. This does not affect the delay until inflation as it controls by the degradation rate of the inner vessel. Hard gelatin capsules are suitable containers to facilitate patient swallow the device. Of course, this drink can also be facilitated and the device can reach the stomach more quickly if the patient swallows the device with a drink of Water.

The volume that the ball should occupy when infla affects the amount of the emission substance and the acid optional solid that is required as well as the amount of film or Cloth material used to make the ball. These factors They affect the size of the ball after it is compacted. The conventional larger dimension of hard gelatin capsule Designed for oral administration, to humans is the capsule of dimension 000. The largest balls of this invention that can 600-800 mL inflated will not be compacted necessarily to that dimension. The containers for balloons 600-800 mL preferably measures approximately 2 cm to approximately 6 cm by approximately 0.5 cm a approximately 2 cm by approximately 0.5 cm to approximately 2 cm. More preferably the container for such balls is of approximately 4 x 1 x 1 cm. Two pieces of gelatin capsules hard with these dimensions can be easily produced using the techniques described below to make a receptacle and which are also quite known in the art. In addition, a Veterinary capsule is a viable alternative. Although you don't have per object for routine drug administration to humans Due to its large size, many of the veterinary dimensions smaller ones can be swallowed by fully grown adults without no risk The capsules of veterinary dimension preferred for The package is the conventional dimensions 13, 12, 11, 12e1 and 10, which are available for example, from Torpac, Inc. (Fairfield, NJ), the dimension 12e1 being 6 x 1.3 cm especially preferred. Veterinary capsules can be used as received by a provider. As an alternative, the same can be modified by cutting, reforming and resealing to Obtain a container of a desired volume. For example, a container of approximately 4 x 1 x 1 cm can be made by trimming the open ends of the capsule halves of dimension 12e1 in a point that allows the remaining portions of the halves of capsules are pressed together to a length not greater than about 4 cm In addition, a segment can be removed longitudinal capsule halves, and the edges can be reseal to reduce the cross-sectional dimensions of the capsule. When a plurality of balls are used self-inflating smaller volumes, the device can be sized to fit in a 000 capsule or even smaller designed for oral administration Routine human drugs.

Therefore, having described the device doctor of the present invention with reference to its components functional, will now be further illustrated with a description of the exemplary embodiments depicted in the figures.

Now with reference to Figure 1 and in particular to Figure 1 (a) in which a intragastric self-inflating device 1 of according to the present invention. As illustrated, the device 1, includes an air chamber 2. The air chamber 2 can assume any form after inflating it, for example, spherical, oblong, drum or elongated. In addition, the ball can have a contoured surface to facilitate the transport of food from the heart to the pylorus or to minimize the contact between the balloon and the stomach wall as taught in United States Patent No. 4,416,267, 4,694,827, 4,739,758 and 4,899,747 or may have other surface contours. Preferably, the air chamber 2 assumes a generally spherical after inflation.

The air chamber 2 can be made of any material substantially impermeable to liquids. He material can be non-elastic or semi-elastic, such as Dacron®; Nylon® and the like, Nylon® being preferred. How alternatively, the material can be highly elastic, such as a rubber, latex or the like. In addition, the air chamber may have a mono-layer, a bi-layer or a multilayer construction. For example, an air chamber can have an inner layer of Nylon® or a vinyl ethyl acetate and can have an outer silicone layer for better biocompatibility In addition, the material substantially impermeable to liquid could contain a radiopaque substance to allow visualization of the globe in the patient's stomach. How alternatively, the ball could have a band of radiopaque material like a metallic paper around its circumference to enable display

In the device of Figure 1 (a), the Deflated balloon lengthens and has an open end. A septum 3 it is positioned in the opening of the air chamber 2 and fits fluid tight form on the inner surface of the chamber of air. The septum and the air chamber can be adhered by any adhesive that forms a fluid tight seal between the Septum and the air chamber. They can also be fitted by means of clamps 4 that circle the open end of the ball around the septum As illustrated in Figure 1 (a), a rigid case 5 can circle the septum 3 and mediate the seal fluid tight between the septum 3 and the air chamber 2.

The exemplary device of Figure 1 (a) it also has a receptacle 6 formed of a protective material soluble. As illustrated, receptacle 6 generally has cylindrical shape and has an open end, or mouth, and an end closed, like one half of a gelatin capsule. A receptacle Especially preferred is made from gelatin and has a volume internal from about 1 cm3 to about 3 cm3, more preferably from about 1 cm3 to about 2 cm3, and most preferably is about 1.7 cm3. A Jelly receptacle can be made using quite a few techniques known in the field. A gelatin solution is prepared in Water. A stainless steel screw dips into the solution and then removed. A jelly film that adheres to the end of the screw dries with heat and / or air of circulation. Once dry, the hardened jelly can slide outside the end of the roll and, if necessary, its edges are They can weft to produce a smooth mouth surface. The spesor of the receptacle wall can be adjusted by varying the viscosity of the gelatin solution and thus controlling the duration of the time between activation and inflation. A receptacle of any desired near dimension can also be made to from the gelatin capsules available in the market. The commercially available capsules consist of two halves of capsules If neither of the capsule halves of one size conventional has the desired volume, then you can use the capsule half that fits over the other to increase the volume of half of smaller capsule. The closed end is Trim half of larger capsule. The tubular segment of half of larger capsule slides over half of capsule smaller and positioned so that half the capsule modified has the desired internal volume. A solution of viscous jelly can be painted along the edge of the segment tubular circling the smaller half capsule to make it Airtight dries fluid after it dries.

The mouth of the receptacle 6 must be soft so that it will join the surface of the septum that faces the interior with a fluid tight seal. The seal can be made with any non-toxic adhesive that provides a tight seal to fluid. The seal can also be made by moistening the mouth of the receptacle which causes the soluble protective material to soften and then press your mouth against the septum until the It dries and re-hardens.

In an illustrative embodiment of Figure 1 (a), an emission substance 7 is contained within the lumen of the air chamber 2. To activate the device represented in Figure 1 (a), a liquid organic acid or mineral or organic acid solution is injected through sept 3 inside the container 10. In this description, the same numbers indicate the same parts in the drawings.

In another illustrative embodiment represented in Figure 1 (b), the lumen of the air chamber 2 contains in addition the emission substance 7 (indicated by the "o"), a solid acid 8 (indicated by the "x"). To activate the device shown in Figure 1 (b), a aqueous solution, preferably substantially pure water through from septo 3 inside the container 10.

In another illustrative embodiment represented in Figure 1 (c), the emission substance 7 is contained in the lumen of the air chamber 2 and a solid acid 8 is contained In the container. To activate the device represented in the Figure 1 (c), an aqueous solution, preferably substantially pure water is injected through septum 3 into the container 10.

In another illustrative embodiment represented in Figure 1 (d), the emission substance 7 is contained inside the container and a solid acid 8 is contained within the lumen To activate the device shown in Figure 1 (d), a non-acidic aqueous solution, preferably substantially pure water is injected through septum 3 into of container 10. Figure 1 (d) also illustrates another building. In the device of Figure 1 (d) the ball It is made of a self-sealing material. The septum 3 is integrated into the ball and constitutes a thickened portion of the Balloon wall formed during molding. Of course the choice  of the placement of the emission substance 7 and the solid acid 8 Optional can be drawn up regardless of the details of device construction.

Figure 2 illustrates the use of the device. In Figure 2 (a), the device of Figure 1 (a) has been compacted and encapsulated in container 9, in this case a capsule 12e1 hard jelly has been trimmed as described previously. Figure 2 (b) shows the injection of the acid inside the container 10 defined by the receptacle 6 the face interior of the septum 3. Immediately after swallowing it, the device 1 goes down the esophagus (Figure 2 (c)) and It reaches the stomach. In the stomach, the container degrades under the action of the gastric fluid and then the vessel wall penetrates allowing contact between the acid and the substance of emission (Figure 2 (d)). Gas emission inflates the ball (Figure 2 (e)) until the emission substance is consumed and / or acid, at which point the balloon must be inflated to a volume (Fig. 2 (f)) approximately predetermined and controlled by the amount of emission substance present in the ball. The amount of emission substance can be determined by routine experimentation or through knowledge of the stoichiometry of the gas generation reaction, the weight of Emission substance formula, the desired pressure within the ball and the ideal nature of gas. When the emission substance it is sodium bicarbonate or potassium bicarbonate and the balloon is dimensions to occupy approximately 200 cm3 to about 800 cm3, then the amount of substance of broadcast used will typically be in the range of approximately 1 g to approximately 8 g.

The convenience benefit is provided to patient and medical staff by the invention either because the ball deflates automatically or because it deflates manually and removed by a medical procedure.

Another aspect of the invention is the proportion of a device that occupies intragastric volume that is auto-deflate after a period of time prolonged approximately predetermined. During ordinary use, the device will reside in the stomach of the subject throughout the period between inflation and deflation. Preferably, the ball remains inflated for approximately 20 days to approximately 60 days.

After deflation, the device can pass through the pylorus and the rest of the digestive system without damaging it.

Deflation is achieved in the device self-deflation of the present invention using slowly biodegradable material, degradable acid or pepsin biodegradable (hereinafter "degradable materials") in its building. Therefore, the cover 5 can be made using a material that degrades in the stomach. As an alternative, Clamp means can be made from degradable materials. Preferred biodegradable materials from which make a cover or clamp degradable are polyglycolide (Dexon®), poly (1-lactide), poly (d, 1-lactide), poly (lactide-co-glycolide), poly (x-caprolactone), poly (dioxanone), poly (carbonate) glycolide-co-trimethylene), poly (hydroxybutyrate-co-hydroxyvalerate), polyglyconate (Maxón®) polyanhydrides or polyorthoesters. Other more preferred biodegradable materials are polydioxanone, Monocryl® (polyglecaprona) and Vicryl®. A degradable material Especially preferred is the biodegradable suture material, more particularly suture material made from polyglyconate (Maxón®), polyglycolide (Dexón®), poly (x-caprolactone) also available from Ethicon, Inc. (Somerville, NJ) under the trademark Monacryl® and poly (dioxanone), also available from Ethicon Material combinations can also be used. polymeric These could be used where the properties of Combined polymers contribute to improve the functioning of the device. For example, a resorbable polymer can be mixed with a more rigid degradation polymer, slower to achieve the qualities of the initial rapid degradation of most of the structure while maintaining a rigid frame during longer periods of time.

Another additional alternative is to manufacture the camera of degradable material air. For example, the ball can be made from Vicryl® (Ethicon) or PDS®.

The devices of self-deflating according to this invention must be packaged and stored under drying conditions to avoid Possible premature degradation.

Claims (11)

1. An intragastric medical device of self-inflated (1) comprising:

one)

a balloon (2) deflated, ingestible, substantially impermeable to liquid that has an outer surface and a surface interior, the interior surface limiting to a lumen;

2)

a emission substance (7) enclosed within the ball, in which the emission substance is a substance that releases gas when it does contact with a reagent;

characterized in that the device comprises

3)

a container (6) enclosed within the ball and enclosing a space inside the ball separated from the lumen, in which at least a portion of the container is manufactured from a soluble protective material that is soluble in at least one liquid selected from a group which consists of:

one.

Water,

2.

organic acids that are liquid to room temperature, and

3.

mineral acid solutions or organic;

and in which container comprises an opening, in which the container is also fixed in the opening to a septum (3) by means of a liquid impermeable seal (5); and in which the septo is a self-sealing valve that provides fluid communication within the container from the outside of the ball.

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2. The intragastric device of self-inflating of claim 1 wherein the balloon is formed of a non-self-sealing material that it has an opening, in addition, in which the opening closes for the passage of a liquid through the valve self-sealing 3. The intragastric device of self-inflating of claim 2 wherein the self-sealing valve is positioned in the opening of the ball and is held in the opening with a waterproof seal liquid. 4. The intragastric medical device of self-sealing of claim 1 comprising also a container that encloses the ball and sized to allow the passage through the esophagus. 5. The intragastric medical device of self-inflating of claim 1, wherein minus a portion of the device in communication from the inner surface until the outer surface of the balloon is formed of a material that degrades under conditions of use if orally administered to a subject, the portion that degrades causes that the ball deflates after a period of time within the subject. 6. A kit comprising:

one)

he intra-gastric self-inflating medical device claim 1; Y

2)

a syringe.

In which the syringe is pre-filled with a activation fluid selected from the group consisting of water, organic acids that are liquid at room temperature, mineral acid solutions and acid solutions organic

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7. The kit of claim 6 wherein the activation liquid is selected from the group consisting of a solution of a citric acid, an acetic acid, an acid aqueous acetic acid and an aqueous hydrochloric acid. 8. The kit of claim 7 wherein the activation liquid is comprised of a mixture of about 25% to about 50% (v / v) acid acetic and from about 50% to about 75% (v / v) of water. 9. The kit of claim 6 wherein the activation liquid is comprised of a mixture of approximately 33% acetic acid and approximately 67% (v / v) of water.